Tools, Templates, and Resources
This set of documents is intended to provide an organized resource for the tools, templates, and other resources needed to conduct clinical and translational research at OHSU. Let the OCTRI Navigator know if there is anything else that would be helpful for you to see here: octri@ohsu.edu.
General Study Start Up Information
OHSU institutional contracting information (for industry sponsored research)
OHSU research pharmacy services general information sheet
IRB review board membership and FWA information
OHSU institutional information for grants/contracts
Information about process and billing aspects for device studies
OHSU Clinical Engineering form to review medical devices and equipment
Information about OHSU's electronic health record system
Lab information and normal ranges:
Proposal Development
As you begin to develop your grant proposal and create your clinical research protocol these resources may be useful. Be sure to give ample consideration and time to ensuring your project is feasible.
Proposal Development:
- OCTRI's Clinical Research Development Team or Design Studio
- Data and safety monitoring plan assistance - contact OCTRI's Regulatory Knowledge and Support
- Data and safety monitoring plan for OHSU's IRB
- Data and safety monitoring board training guide, provided by Tufts CTSI
- NIH Data Management & Sharing Policy help through the OHSU Library
- NIH Sample Data Management & Sharing Plans
- OHSU Library resources related to working with data
Protocol Development:
- Protocol feasibility checklist
- Clinical trial protocol example outline
- Clinical trial protocol example checklist
- OHSU's IRB protocol templates - open the accordion titled "Protocol Templates"
Protocol examples
A sample of OCTRI's boiler plate template for inclusion in funding proposals can be downloaded below.
If you are submitting a funding application with specific OCTRI resources, you must request a cost estimate to include in the proposal budget. Without a cost estimate on file we cannot guarantee the resources you plan on using will be available or feasible for your project.
Please complete our Resource Request Form to submit a request for a cost estimate and letter of support.
Budgeting
Budgeting for a clinical research study can be a complicated high contact activity. Here we have assembled some templates, tools and links to assist in the budgeting process.
Budget development — administrative guidance on developing a budget for grants
Industry budget and payment terms guidelines
Industry-sponsored clinical trial budget checklist
OHSU Fixed Fee Memo for Industry studies
Research Staff Effort Calculator
OHSU research rates approval process and account request
OHSU Research Administration Training and Education (RATE) shared document library
Study Conduct
To make the conduct of your study go a bit smoother, we have compiled a collection of information, tools and templates for your day to day activities. If you have a great tool that you would like to share please contact us.
Scope of practice for research assistants/associates
Scope of practice for support staff in ambulatory care settings
Research coordinator training requirement checklist
Acronym and General Clinical Research Contacts guide
Study Management:
- Study management checklist — an example of a checklist of tasks required for the management of a clinical study
- Clinical trial regulatory file checklist
- Study-specific training sign-in log — an example of an in-service document log
- Delegation of authority log
- Laboratory list/log — an example of a log to document the laboratories that will be used in a study and the contact information for each laboratory
- Specimen log — an example of a form to track the collection and distribution of study-related biological specimens
- Protocol violation documentation form — an example of a form that can be used to document protocol violations and deviations
- Subject reimbursement ClinCard - the OHSU approved research participant payment process
Study Subject Tracking Templates and Examples:
- Study subject schedule tracker
- Study subject screening tracker
- Comprehensive subject tracker
- Subject drug log — an example of a log to be used for a research subject to track taking their study drug
- Subject ID card template — used for subjects to know contact information and where research is being conducted
- Adverse Event (AE) tracking log example
Using Epic for Research:
- Epic For Research 02 site
- Epic access for OHSU research staff request form (Note: Epic research class required prior to access)
- Epic access for research monitors/auditors request form - please email this to ResearchCrdHIMclbtn@ohsu.edu
- Epic for Research forms and tools (ITG's Bridge Site)
- Care Everywhere FAQ for use guidance related to research
- Scheduling Research Patients in Epic, see Tip Sheet on the Epic for Research Bridge Site
- Acceptable use of MyChart for Research Coordinators (policy)
- Genetic Opt-Out Training and Access to the Genetic Opt-Out Database (provided after training is complete)
Clinical Trial Registration:
- Clinical trials registration (CT.gov) quality control checklist
- ClinicalTrials.gov OHSU Sharepoint for resources and information
FDA Audits:
Knight Cancer Institute
Clinical Research Policies, Procedures and Central Offices
Under the following accordions you will find a listing of policies and procedures you should be aware of when conducting clinical research at OHSU. Note that this list may not be comprehensive.
OHSU policy manual — includes research-related policies
OHSU distinguishing gifts from grants, contracts and other sponsored projects 04-40-01
OHSU sponsored project budgets and cost coverage 04-40-020
Research record retention requirement summary
Clinical Research Billing Office (CRBO) policies
Clinical Trial Office (CTO) contracting policies
Conflict of Interest in Research (COIR) policies
Institutional Biosafety Committee (IBC)
Institutional Review Board (IRB)
Office of Proposal and Award Management (OPAM) policies and guidance
Clinical trials registration for investigator-initiated trials
OHSU healthcare policy database — includes all healthcare-related policies
Adverse drug reaction reporting
Authorization to Handle, Transport and Administer Medication Policy
Authorization for use and disclosure of protected health information
Innovative procedures for therapies
Investigational agents consisting of recombinant DNA for infectious agents
Permitted uses and disclosures of protected health information
Uses of protected health care information that require written authorization
Research documentation in the integrated health record
Billing of research-related clinical services, research rates and research account setup
Right to an accounting disclosures of health information
Right to request access to inspect or obtain a copy of protected health information
Use of research devices and equipment
Ready to discuss your needs?
Contact an OCTRI Navigator for guidance and support.